FDAClass IIJune 12, 2013

Dallergy TABLETS recall: CGMP Deviations

Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC…

Why was Dallergy TABLETS recalled?

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14.

Product
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC…
Recalling firm
TG United, Inc.
Quantity
31,739 bottles 100-count; 842,617 Bulk tablet bottles
Distribution
FL, MS, SC, LA and TX
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls